Ignite Creation Date:
2025-12-24 @ 9:36 PM
Ignite Modification Date:
2025-12-25 @ 7:19 PM
Study NCT ID:
NCT07178132
Status:
COMPLETED
Last Update Posted:
2025-09-24
First Post:
2025-09-10
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Use of PNF and Tissue Flossing to Treat Hamstring Tightness in Young Female Students
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D052580', 'term': 'Muscle Stretching Exercises'}], 'ancestors': [{'id': 'D005081', 'term': 'Exercise Therapy'}, {'id': 'D012046', 'term': 'Rehabilitation'}, {'id': 'D000359', 'term': 'Aftercare'}, {'id': 'D003266', 'term': 'Continuity of Patient Care'}, {'id': 'D005791', 'term': 'Patient Care'}, {'id': 'D013812', 'term': 'Therapeutics'}, {'id': 'D026741', 'term': 'Physical Therapy Modalities'}, {'id': 'D015444', 'term': 'Exercise'}, {'id': 'D009043', 'term': 'Motor Activity'}, {'id': 'D009068', 'term': 'Movement'}, {'id': 'D009142', 'term': 'Musculoskeletal Physiological Phenomena'}, {'id': 'D055687', 'term': 'Musculoskeletal and Neural Physiological Phenomena'}]}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2025-09-19', 'size': 181708, 'label': 'Study Protocol and Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'Prot_SAP_000.pdf', 'typeAbbrev': 'Prot_SAP', 'uploadDate': '2025-09-19T06:31', 'hasProtocol': True}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'CROSSOVER'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 60}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2024-02-02', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-09', 'completionDateStruct': {'date': '2024-04-15', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-09-19', 'studyFirstSubmitDate': '2025-09-10', 'studyFirstSubmitQcDate': '2025-09-10', 'lastUpdatePostDateStruct': {'date': '2025-09-24', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2025-09-17', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2024-04-10', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Active Knee Extension Test', 'timeFrame': 'From enrollment to the end of treatment at 1 week', 'description': 'With the participant supine and the hip flexed to 90°, the participant actively extends the knee. A goniometer was used to records the knee extension angle. Three trials are performed and the mean is used for analysis.'}, {'measure': 'Passive Knee Extension Test', 'timeFrame': 'From enrollment to the end of treatment at 1 week', 'description': 'With the participant supine and the hip flexed to 90°, the examiner passively extends the knee until the first onset of resistance. A goniometer is used to records the knee extension angle. Three trials are performed and the mean is used.'}, {'measure': 'Straight Leg Raise', 'timeFrame': 'From enrollment to the end of treatment at 1 week', 'description': 'With the participant supine, the examiner passively raises the extended leg until resistance . A goniometer at the hip measures maximum hip flexion angle (degrees). Three trials are performed and the mean is used.'}, {'measure': 'Sit-and-Reach Test', 'timeFrame': 'From enrollment to the end of treatment at 1 week', 'description': 'The participant sits with legs extended and reaches forward along a standard sit-and-reach box . After a warm-up, three trials are performed and the mean score (cm) is recorded.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['tightness', 'tissue flossing', 'proprioceptive neuromuscular facilitation', 'Hamstring tightness', 'flexibility'], 'conditions': ['Hamstring Tightness', 'Muscle Tightness']}, 'descriptionModule': {'briefSummary': 'The goal of this clinical trial is to learn tissue flossing and proprioceptive neuromuscular facilitation effect in treating hamstring muscle tightness.\n\nThe main questions it aims to answer are:\n\n1. which technique is more useful in giving instant relaxation of hamstring muscle\n2. can these technique increase muscle flexibility and knee motion\n\nResearchers will compare Tissue flossing to a PNF (Proprioceptive neuromuscular facilitation) to see which on is more effective.\n\nParticipant will:\n\n1. be provided one technique either tissue flossing or PNF in first day\n2. physiotherapist will immediately measure the the change in flexibility or knee motion\n\n2\\. another technique will be applied after 1 week 3. again change in flexibility and knee motion will be recorded'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT'], 'maximumAge': '25 Years', 'minimumAge': '18 Years', 'genderBased': True, 'genderDescription': 'Only female participants were eligible for inclusion in this study. The study focused on young women because sex-related differences in hamstring flexibility, joint range of motion, and neuromuscular properties have been reported in the literature. Restricting the sample to female students provided a more homogeneous group and reduced variability related to gender differences, thereby enhancing internal validity', 'healthyVolunteers': True, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Female subjects were included in the study\n* Subjects with hamstring muscle tightness were included\n* Subjects between the age group of 18-25 years were included\n\nExclusion Criteria:\n\n* Male subjects\n* Subject who didn't fulfill the age criteria\n* Subject with hamstring tear or other knee ligament injury\n* Any history of lower limb surgery dating back a year\n* Subjects with Lower back pain or any neurological compromise in the lower limb\n* Any acute injury like a sprain, strain, and open wound\n* Subjects who had latex allergies\n* Subjects with venous thrombotic disease, heart disease, respiratory illness, and dermatitis, in their lower legs were excluded"}, 'identificationModule': {'nctId': 'NCT07178132', 'acronym': 'Tightness', 'briefTitle': 'Use of PNF and Tissue Flossing to Treat Hamstring Tightness in Young Female Students', 'organization': {'class': 'OTHER', 'fullName': 'Guru Nanak Dev University'}, 'officialTitle': 'Comparative Effects of Tissue Flossing and Proprioceptive Neuromuscular Facilitation on Hamstring Flexibility and Knee Range of Motion in Young Female Students', 'orgStudyIdInfo': {'id': '2250/HG'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Tissue Flossing Arm', 'description': 'Application of tissue floss band to hamstring muscle at moderate tension for 2 minutes, followed by flexibility testing via AKET (Active Knee Extension Test), PKET (Passive Knee Extension Test), SLR (Straight Leg Raise), and Sit-and-Reach.', 'interventionNames': ['Other: tissue floss band']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'PNF Hold-Relax Arm', 'description': 'Standard PNF hold-relax stretching technique of hamstring, followed by flexibility testing via AKET (Active Knee Extension Test), PKET (Passive Knee Extension Test), SLR (Straight Leg Raise), and Sit-and-Reach.', 'interventionNames': ['Other: Proprioceptive Neuromuscular Facilitation']}], 'interventions': [{'name': 'tissue floss band', 'type': 'OTHER', 'otherNames': ['Floss band'], 'description': 'Floss band is wrapped in thigh from distal to proximal for 2 minutes. during this period patient is asked to actively perform movement for 2 minute, after that the band is removed and repeated once more. Immediately followed by flexibility measurements', 'armGroupLabels': ['Tissue Flossing Arm']}, {'name': 'Proprioceptive Neuromuscular Facilitation', 'type': 'OTHER', 'description': 'Proprioceptive Neuromuscular Facilitation (PNF) Stretching using the hold-relax method: participants perform an isometric contraction of the hamstring at the end of its stretch range , followed by relaxation and passive stretch, then flexibility assessed similarly', 'armGroupLabels': ['PNF Hold-Relax Arm']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Amritsar', 'state': 'Punjab', 'country': 'India', 'facility': 'Guru Nanak Dev University', 'geoPoint': {'lat': 31.62234, 'lon': 74.87534}}], 'overallOfficials': [{'name': 'Manpreet Kaur, MPT', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Guru Nanak Dev University'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO', 'description': 'I did not include individual participant data in ClinicalTrials.gov to protect participant privacy and confidentiality.'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Sakshi Negi', 'class': 'OTHER'}, 'collaborators': [{'name': 'Guru Nanak Dev University', 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR_INVESTIGATOR', 'investigatorTitle': 'Principal Investigator', 'investigatorFullName': 'Sakshi Negi', 'investigatorAffiliation': 'Guru Nanak Dev University'}}}}